BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 16102376 · Received January 5, 2023

    Report

    Report Number
    3001722928-2023-00001
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 8, 2022
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    UDI-DI
    04547410295900
    PMA / PMN Number
    K183032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PERFORATION OCCURRED NEAR WHERE THE OVERTUBE BALLOON CAME INTO CONTACT WITH THE INTESTINAL WALL. IT WAS NOTED THAT THE PATIENT'S INTESTINAL TRACT COULD BE MORE SUSCEPTIBLE TO INJURY DUE TO HER OLD AGE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO FDA AS A RESULT OF FUJIFILM CORPORATION'S COMMITMENT TO PERFORM A RETROSPECTIVE REVIEW OF ALL MDRS SUBMITTED BETWEEN (B)(6) 2021 AND (B)(6) 2023, DUE TO FDA 483 OBSERVATIONS ISSUED TO FUJIFILM CORPORATION ON (B)(6) 2023. THIS SUPPLEMENT INCLUDES MISSING OR INCORRECT INFORMATION IN THE ORIGINAL MDR FILING, AND PREVIOUS SUPPLEMENTS WHERE APPLICABLE.

    Additional Manufacturer Narrative · 0

    ON JANUARY 27, 2023, FUJIFILM CORPORATION CONCLUDED THE ROOT CAUSE INVESTIGATION OF THE EI-580BT AND PB-20 BALLOON CONTROLLER. IT WAS CONFIRMED THAT THERE WAS AN AIR LEAK IN THE PB-20 AIR SUPPLY TUBE AND INTAKE TUBE CAUSED BY GAPS AND AGING. HOWEVER, THESE MALFUNCTIONS HAVE NO IMPACT ON THE MAXIMUM AIR SUPPLY VOLUME/PRESSURE AND CANNOT BE CONTRIBUTED TO THE PERFORATION. THERE WERE NO ABNORMALITIES OBSERVED ON THE INSERTION PORTION OF THE SCOPE, AND NO DEFECTS WERE NOTED THAT WOULD IMPEDE THE INFLATION/DEFLATION OF THE BALLOON IN THE AIR SUPPLY CHANNEL. THE OVERTUBE AND BALLOON WERE DISCARDED AT THE FACILITY AND WERE UNABLE TO BE INVESTIGATED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON DECEMBER 9, 2022, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EI-580BT. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) A PERFORATION OCCURRED IN THE INTESTINAL TRACT. AN OVER-THE-SCOPE CLIP SYSTEM WAS USED TO CLOSE THE PERFORATION AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DEATH REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255255 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EI-580BT N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention